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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007920
Receipt No. R000009327
Scientific Title The effect of salt restriction on protein intake.
Date of disclosure of the study information 2012/05/10
Last modified on 2014/05/13

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Basic information
Public title The effect of salt restriction on protein intake.
Acronym The effect of salt restriction on protein intake.
Scientific Title The effect of salt restriction on protein intake.
Scientific Title:Acronym The effect of salt restriction on protein intake.
Region
Japan

Condition
Condition hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of salt restriction on dietary protein intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes urinary urine nitrogen concentration
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria patients with hypertension receiving salt restriction diet
Key exclusion criteria patients receiving protein restriction diet
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko KANNO
Organization School of medicine, Tokyo Medical University
Division name Department of nephrology
Zip code
Address 6-7-1 Nishi Shinjuku, Shinjuku, Tokyo
TEL 03-3342-6111
Email kannoyh@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosihihiko KANNO
Organization Tokyo Medical University
Division name Department of Nephrology
Zip code
Address 6-7-1 Nishi-Shinjuku, Shinjuku, Tokyo
TEL 03-3342-6111
Homepage URL
Email kannoyh@tokyo-med.ac.jp

Sponsor
Institute Department of Nephrology, Tokyo Medical University
Institute
Department

Funding Source
Organization Apheresis and Dialysis Center, School of Medicine, Keio University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大田原赤十字病院(栃木県)、静岡県立静岡病院(静岡県)、東京労災病院(東京都)、北彩都病院(北海道旭川市)、社会保険大宮病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measuring urinary concentration of sodium, urea nitrogen, creatinine

Management information
Registered date
2012 Year 05 Month 09 Day
Last modified on
2014 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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